Made to measure. Since HYGIENIC PRESSURE AND TEMPERATURE MEASUREMENT. Principles Design Applications

Transcription

1 Made to measure. Since HYGIENIC PRESSURE AND TEMPERATURE MEASUREMENT Principles Design Applications

2 CONTENTS WITH EXPERIENCE... About LABOM 2 Measuring Technology in Sensitive Environments Hygienic Design of Pressure and Temperature Measuring Equipment 4 Objectives and Principles of Design at LABOM 6 Integration in Processes Temperature Measuring Process Connections 12 Pressure Measuring Process Connections 14 Glossary of Terms 16 Made to measure 18 LABOM FROM STANDARD TO SPECIAL REQUIREMENTS LABOM is one of the leading quality manufacturers in industrial pressure and temperature measurement. We have specialised in the measurement and monitoring of pressure and temperature, as well as derivable variables, like level and flow. Besides a wide range of standardised products, our strength lies in meeting customers individual requirements. Working in partnership we develop Made to measure solutions. MiniTherm resistance thermometer PASCAL CV pressure transmitter Hygienic diaphragm seals

3 KNOWLEDGE AND EXPERTISE HYGIENE REQUIREMENTS Strict national and international regulations govern products, which can directly or indirectly influence the health of humans. The requirements include the protection of health and environment, reproducible quality and traceability. The hygienic design of the measuring equipment is the prerequisite for the production of flawless products. GIVING GERMS NO CHANCE Select the design and layout of the measuring equipment for reliable operation to ensure that components can be properly cleaned. The equipment must eliminate the possibility of the product becoming contaminated, as germs cannot be allowed to penetrate nor multiply. With closed systems, this means that automatic cleaning (CIP) and sterilisation (SIP) processes are safe and reliable to use. EXCLUSIVELY FOR FOOD, PHARMA- CEUTICALS AND BIOTECHNOLOGY Hygienic solutions are of key importance for users in these sectors. LABOM specifically produces special HY-labelled products on its in-house production line for these sectors. Fundamentally, we guarantee outstanding precision and long-term reliability for all LABOM-brand measuring equipment. EVERYTHING FOR SAFE PRODUCTS Use of a dedicated in-house production line (HY) Production almost exclusively at our plant in Germany Suitable materials, like high-quality steels, FDA-listed sealing materials, plastic coatings and diaphragm seal oils Traceability of the materials used Traceability of the production and test stages Inspection certificates by independent staff DIN EN ISO 9001:2008 QM certification 2 3

4 MEASURING TECHNOLOGY IN SENSITIVE ENVIRONMENTS

5 DESIGNING HYGIENIC PRESSURE AND TEMPERATURE MEASURING EQUIPMENT LABOM offers a whole range of solutions that meet hygienic design requirements to meet hygienic and aseptic demands. The equipment is compatible with Cleaning in Place (CIP) and Sterilisation in Place (SIP) cycles. The selection of materials, the design of measuring equipment, its production and installation in manufacturing facilities is optimised and tailored to the respective application. KEY MEASURES: Avoidance of constructive dead zones, gaps and edges Flawless surfaces with minimal roughness Flush-mounted components Use of non-corrosive steel Use of suitable sealing materials and seal shapes Self-draining design of measuring equipment Enhanced assembly and dismantling of measuring equipment LABOM hygienic measuring equipment is EHEDG-certified and produced on the basis of well-defined principles. DIVERSE CUSTOMER APPLICATIONS LABOM measuring equipment can be used in the most diverse applications: from pressure measurement in cross-flow filtration systems to sterilisation temperature monitoring in the production of anti-cancer drugs to the measurement of the filling level of beverage concentrates in the food industry. 4 5

6 OBJECTIVES AND PRINCIPLES SMOOTH SURFACES The structure and roughness of a surface is a crucial factor in the cleaning of dirt and micro-organisms. Only a flawless surface without scratches, pores, fissures and cracks can be cleaned and sterilised by automated processes. The differences can only be seen under a microscope. An average roughness value of Ra < 0.8 µm on flat surfaces and in welding seam areas is generally sufficient to ensure good surface cleanability. It is hard to achieve improved cleanability at roughness values below Ra = 0.4 µm. The wetted areas of LABOM equipment are supplied with the adjacent surface roughness classes. Surface roughness is not necessarily improved by electropolishing but generates a homogeneous passive layer with minimal adhesion for dirt. Poor cleanability Enhanced cleanability Code HY HY06 HY04 Turned parts Ra < 0.8 µm Ra < 0.6 µm Ra < 0.4 µm Diaphragm foils Ra < 0.4 µm Ra < 0.4 µm Ra < 0.4 µm Weld seams Ra < 0.8 µm Ra < 0.8 µm Ra < 0.8 µm Milled: Ra = 0.24 µm Electropolished: Ra = 0.18 µm (Comparison of 500 x magnified diaphragm surfaces)

7 NO GAPS AND EDGES The design makes the difference: In attempting to ensure that systems and equipment meet the purpose for which they were originally designed, it must be accepted that hygienic necessities can sometimes come into conflict with hygienic requirements. There should be no gaps and edges, but, at the same time, the equipment has to work perfectly. Poor design Ideal design: Meets the requirements for aseptic connections Hygiene safety always has priority in the search for an acceptable compromise. LABOM has a lot of experience in the process industry and offers a range of different hygienic or aseptic process connections. FEATURES OF ASEPTIC PROCESS CONNECTIONS Self-centring by a cylindrical guide creates a gap-free seal towards the inside of the pipe Metallic stops ensure that the seal is subjected to a defined pressure Space to allow for thermal expansion on the side facing away from the process 6 7

8 FURTHER OBJECTIVES AND PRINCIPLES NO DEAD ZONES Dead zones are produced by abrupt changes in diameter or the ends of blind pipes, among other things. Hygienic design of measuring points should aim to avoid dead zones, as they can lead to problems during cleaning. Basically the rule is: The higher the flow rate of a cleaning agent, the better the result. HOW DEAD ZONES ARE PRODUCED Diameter increases Diameter narrows Blind pipe end Improved solutions have to be found for the local geometry for optimum flow. Ideally, there should be no dead zones. SOLUTIONS FOR MEASURING DEAD ZONES Measurement of pressure with an inline diaphragm seal (part of the pipe) Measurement of temperature with a pipe sensor (part of the pipe) Measurement of the surface temperature (external / clamp-on technology) SELF-DRAINING Self-draining is a key issue in plant and pipe installation. The EHEDG recommendations are as follows: The interior and exterior of all equipment, components and pipes has to be self-draining or capable of being drained and easy to clean. Avoid horizontal surfaces; ensure that they are always inclined to one side. Design external surfaces so that any fluids can flow away from the product area.

9 GASKETS THE RIGHT MATERIALS Instruments and equipment components are adapted to the process using proven connection technology and gaskets. A gasket has to function properly throughout its entire service life under all process and cleaning conditions and can either be designed as O-ring or gasket. CORROSION-FREE STAINLESS STEEL Stainless steel provides excellent corrosion protection under the process conditions of applications in the food, pharmaceuticals and biotechnology industries. The selection of the appropriate stainless steel for the specific application depends largely on the corrosiveness of the process and the cleaning agents. Mechanical stress and mouldability, weldability, hardness and cost are further relevant factors. (In this respect refer to the EHEDG Recommendation on Construction Materials Doc 32) STAINLESS STEELS USED Stainless steel housing (304) and (316) Wetted parts: Stainless steel and (316L) Higher grades of stainless steel on request, for instance in compliance with the Basle Standard BN2 or with reduced delta ferrite content FLUIDS AND OILS Pressure transmission fluid, FDA-listed silicone-free and synthetic oil as standard Other options: medical white oil (FDA-listed), glycerine / water SELECTION CRITERIA The following must apply to all materials under normal conditions: Corrosion-resistant Chemically inactive REQUIREMENTS The gaskets have to have mechanical and chemical resistance to the product and the cleaning agents within the specified temperature range. Furthermore, controlled compressive loading has to be guaranteed, taking into account the thermal expansion of the seal material. Smooth surfaces to reduce the adhesion of particles, adequate elasticity and neutrality in terms of colour and taste are further requirements that have to be taken into account in accordance with the guidelines and regulations. Resistant to the fluid to be measured Resistant to cleaning agents within the specified temperature range Non-toxic 8 9

10 INTEGRATION IN PROCESSES PRESSURE MEASURING INSTRUMENTS PASCAL Ci4 pressure transmitter with dairy coupling and inline diaphragm seal CI4120 Mechanical pressure measuring instrument with inline diaphragm seal BH42 TEMPERATURE MEASURING INSTRUMENTS Pt 100 resistance thermometer with inline temperature transducer GA2200 Pt 100 resistance thermometer with clamp connection and replaceable measuring insert GA2540

11 The integration of measuring equipment into production plants is a sensitive undertaking. Any interference in the line can cause risks particularly in the hygienic production of food or medicines. What needs to be taken into consideration? GAP-LESS INSTALLATION It is crucial that the measuring instrument itself is centred by a cylindrical guide, avoiding edges and projections and producing a gap-free seal towards the inside of the pipe. CONNECTION OPTIONS LABOM measuring instruments are available with a range of different connections and can be integrated into the most diverse production facilities. Pascal CS pressure transmitter / pressure switch with Varivent connection CS2110 INSIGHT This double page gives an insight into design examples of process connections, as we have often realised for customers in the food and beverage industry, drug production or biotechnology sector. CLEANING Our equipment is capable of withstanding 140 C hot steam and complies with the conditions for cleaning & sterilisation in place (CIP / SIP). It is also simple to install and dismantle, in the event that equipment has to be removed for cleaning. This is a major benefit for systems that need to be taken apart. CONNECTION TECHNOLOGIES AT A GLANCE Pipe connection systems for in-line applications Flat diaphragm seal Thermowells with various process connections for temperature measuring instruments Design with threaded, clamp and flange connections Metal-to-metal process connections Tubus solutions Manufacturer-specific process connections and custom solutions Clamp-on technologies for non-invasive measurement 10 11

12 CONNECTION TECHNOLOGIES FOR TEM Temperature is one of the most commonly measured values in pharmaceutical manufacturing, to monitor and control the production process and also sterilisation procdures with saturated steam (SIP). INVASIVE TEMPERATURE MEASUREMENT PREFERABLY ELECTRIC Electrical measuring equipment is used almost exclusively to process measuring results and comply with documentation requirements. ROBUSTLY INVASIVE The most common method of temperature measurement is to invasively introduce a sensor into the process. This measurement technique is robust and proven. PRECISELY WITH THERMOWELL The conventional immersion probe has been evolved to permit hygienic, invasive measurement using an orbitally welded thermowell system this technique is precise, has no seals and is sterile. INVASIVE CONNECTIONS Conical threaded connection, metal-to-metal seal Union nut as per DIN EN Clamp DIN Clamp ISO 2852 Tri-clamp Varivent Ingold Neumo BioControl / BioConnect Aseptic connections HYGIENIC connections without seals Other connections on request Orbitally welded thermowell system Metal-to-metal sealing MiniTherm fast response MiniTherm for installation in a separate protective tube Resistance thermometer for in-process calibration Field housing with interchangeable measuring insert GA2700 GA2730 GA254. GA2540

13 PERATURE MEASUREMENT NON-INVASIVE TEMPERATURE MEASUREMENT ON THE SURFACE OF THE PIPE A sensor tip reaching into the process represents a significant obstruction to the flow with very small pipe diameters. Measuring the surface of the pipe can be the solution specifically with respect to pharmaceutical measuring tasks: Non-invasive and without the associated hygiene risks. Alternatively, an inline sensor can be integrated in the pipe. NON-INVASIVE CONNECTIONS Inline sensor: Food pipe threaded connection DIN Threaded connection IDF ISO 2853 Clamp connection, ISO 2852-compliant Clamp-on measuring instruments with various clamp elements: Clamping block (for pipe Ø mm) Clamping shoe (for pipe Ø mm) Clamping bracket (for pipe Ø mm) Measurement on the pipe surface With field housing GA2610 / GA2611 With clamping bracket GA2610 Temperature switch GP2610 Inline temperature transducer GA

14 CONNECTION TECHNOLOGI Pressure is one of the most commonly measured values in process engineering, and yet virtually no process is identical to another. The use of diaphragm seal technology is useful for measuring in hygienically sensitive environments. AT A SAFE DISTANCE FUNCTIONAL PRINCIPLE OF DIAPHRAGM SEALS Diaphragm seals are the first choice if there are exceptional requirements governing a measurement task. They separate the measuring instrument from the process media and prevent it from entering into the measuring system - perfect setup for a hygienic solution. NEW SOLUTIONS Measuring tasks are being developed and becoming more highly specialised with increasing automation in the process industry. With patented diaphragms and customer-specific designs for diaphragm seals, LABOM is contributing to precise results and greater operating reliability. CERTIFIED SAFETY A number of LABOM diaphragm seals have been certified by the European Hygienic Engineering & Design Group (EHEDG) as being suitable for cleaning in place (CIP) and sterilisation in place (SIP) applications. This includes the DIN compliant models with flange, clamp or threaded connections, Varivent, NEUMO Biocontrol and the LABOM Hygienic Tubus range. There is also a range of other clamp connections or solutions with union nuts available for applications with less stringent requirements. Pressure transmitting liquid Diaphragm seal Diaphragm Measured media

15 ES FOR PRESSURE MEASUREMENT WITH DIAPHRAGM SEAL PASCAL Ci4 with Varivent connection Ci4110 PASCAL CV with clamp connection CV3010 PASCAL CV with Neumo BioControl connection CV3010 PASCAL CS with dairy coupling CS2110 UNIVERSAL CA with dairy coupling CA2110 COMPACT ECO with clamp connection CA1110 WITH PIPE DIAPHRAGM SEAL PASCAL CV with inline diaphragm seal CV3010 Mechanical pressure gauge with inline diaphragm seal BH

16 GLOSSARY OF TERMS FDA US-3A HYGIENIC DESIGN CIP CLEANING IN PLACE SIP STERILISATION IN PLACE ASEPTIC COMPONENT CORROSION FLAWLESS SURFACE GMP Food and Drug Administration. US Health Authority. A voluntary association of interest groups representing US industry. Aim: To safeguard public health through a programme of hygiene standards for equipment for the production of food. Design of equipment, components and parts to meet specific cleaning requirements. Automated cleaning procedure of closed equipment or a closed process system no dismantling. Automated sterilisation of a closed process system, which removes or kills micro-organisms, often using superheated steam at 120 C or more. A component designed to comply with cleaning regulations, which can be sterilised and is impermeable to micro-organisms. The interaction of a material with its environment, which leads to a change in the properties of the material and possible failure of the component. This interaction is often electrochemical. There are different types of corrosion depending on the corrosion mechanism and the appearance of the corrosion, including pitting, stress-corrosion cracking (SCC) and crevice corrosion. A flawless surface is a surface free of defects, like scratches, fissures, pores and holes, where product residue or cleaning agent and relevant micro-organisms can accumulate. Only a surface that is deemed to be flawless can be easily cleaned. Good Manufacturing Practice: Quality assurance process, mandatory in both the USA and in Europe, in the production of pharmaceuticals and foodstuffs. It covers personnel, premises, documentation, production, quality control and equipment.

17 European Hygienic Engineering & Design Group, founded in 1989 to promote hygienic processes in food production. The EHEDG is made up of professionals from the food industry, suppliers and system installers, research institutes and government bodies. At an international level, the group publishes guidelines and recommendations on Hygienic Design and develops test procedures and assessment criteria. EHEDG EHEDG CERTIFICATION CLASSES The respective system components are categorised in Classes I and II, with Class I relating to equipment that can be cleaned in its installed state (CIP cleaning) and Class II relating to components that can only be cleaned in their dismantled state. Furthermore, parts used in aseptic applications, can be certified as EL Aseptic, while certificate ED relates to components specifically intended for dry cleaning. EL Class I EL Class II EL Aseptic Class I EL Aseptic Class II ED Applies to components that can be cleaned in their installed state (CIP= Cleaning in place). Applies to components that can only be cleaned after they have been dismantled. Applies to components that can be cleaned in their installed state (CIP= Cleaning in place), sterilised (SIP = Sterilisation in place) and are impervious to bacteria. Components for closed processes, which are dismantled for cleaning, can be sterilised with steam and are impervious. Applies to components used in dry processes, which are cleaned dry. All the provisions of EHEDG documents 8, 22 and 26 have to be met

18 MADE-TO-MEASURE SOLUTIONS THE NORTH GERMAN EXPERTS As well as manufacturing standard equipment for the process industry, LABOM is also an experienced specialist in measuring instruments that meet customers individual specifications. LABOM specialises in solving unusual measuring tasks and is more than happy to advise customers. Development, production and sales are located on the same site at its headquarters in Hude (Oldenburg). The company s short lines of communication, large inventory and outstanding vertical manufacturing enables it to produce even small quantities of individual measuring instruments. SELECTION The LABOM portfolio ranges from smart standard instruments, modular designed measuring systems and high-end measuring transmitters to custom configured measuring tasks. INNOVATIONS LABOM solves individual tasks with innovative ideas, like in-process calibration of temperature measuring devi ces or so-called Kombibar equipment with simultaneous electronic and mechanical pressure measurement.

19 STANDARDS LABOM equipment for hygienic use is manufactured in line with GMP (Good Manufacturing Practice) guidelines and meets FDA (Food and Drug Administration) and EHEDG (European Hygienic Engineering & Design Group) standards. QUALITY LABOM s quality management system is DIN EN ISO 9001: certified and complies with the Pressure Equipment Directive 97 / 23 / EC and ATEX 94 / 9 / EC / IECEx

20 ANHANG Norway Nigeria Sweden Finland UK Denmark Ireland Germany Netherlands Belgium Poland France Austria Romania Portugal Italy Spain Greece Turkey Israel Egypt Iran Qatar UAE Russia India China Thailand Vietnam Taiwan Malaysia Singapore Korea Philippines Concept, design and production: I Pictures: I I I Version 1j4 Argentina Brazil South Africa Australia International representatives New Zealand LABOM Mess- und Regeltechnik GmbH Im Gewerbepark Hude Germany P.O. Box Hude Germany Phone Fax info@labom.com